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Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transplant navigator
Usual care
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-70 years old
  • English speaking
  • Mentally competent

Exclusion Criteria:

  • Prior pre-transplant workup
  • Prior kidney transplant
  • Active systemic infection
  • Active or recent malignancy

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Usual care

Navigator will assist patients in completing steps in transplant process

Outcomes

Primary Outcome Measures

Number of Steps Completed in Transplant Process
Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.

Secondary Outcome Measures

Impediments to Successful Intervention

Full Information

First Posted
December 8, 2008
Last Updated
June 20, 2011
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT00805038
Brief Title
Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Official Title
Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Western Reserve University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps. The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator. The proposed project will test a novel intervention that targets patients and nephrologists as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Navigator will assist patients in completing steps in transplant process
Intervention Type
Behavioral
Intervention Name(s)
Transplant navigator
Other Intervention Name(s)
Control: usual care
Intervention Description
Navigator will provide help to patients in completing specific steps in transplant process.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.
Primary Outcome Measure Information:
Title
Number of Steps Completed in Transplant Process
Description
Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.
Time Frame
18-24 months
Secondary Outcome Measure Information:
Title
Impediments to Successful Intervention
Time Frame
18-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old English speaking Mentally competent Exclusion Criteria: Prior pre-transplant workup Prior kidney transplant Active systemic infection Active or recent malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ash Sehgal, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

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